MAUDE Adverse Event Report: MPRI ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 3389-40

Device Problems Break (1069); Difficult to Remove (1528); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a manufacture representative (rep) via a health care professional (hcp) regarding an implantable neurostimulator (ins).It was reported the event occurred during the procedure.Upon opening the lead kit for lead insertion the white spacer collar was missing from the kit.During the lead insertion for deep brain stimulation (dbs) (parkinson's disease) the peel away component of the guide wire was being removed to facilitate the guidewire removal from the inserted lead on the micro targeting system.The white peel away bridge and guide wire sheared off leaving the guidewire intact with the lead.A new lead was open and inserted with no subsequent issues in removing the guide wire.No environmental/external/patient factors were thought to have led or contributed to the issue.No troubleshooting/actions/interventions were performed.The issue was resolved at the time of the report.

Manufacturer Narrative

Continuation of concomitant products: product id neu_stylet_acc, lot# unknown, product type: accessory.Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

On 2019-aug-08 reporter occupation: (for, rep, hcp): additional information was received.There was reportedly no user error related to the event.

Manufacturer Narrative

Concomitant medical products: the main component of the system and other applicable components are: product id: neu_stylet_acc: product type: accessory.Analysis of the lead (lot number:) revealed a packaging part was missing from the kit.Analysis of the stylet (serial/lot number: unknown) revealed the handle and wire were broken.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8811596
• MDR Text Key: 151726076
• Report Number: 2649622-2019-12735
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2023
• Device Model Number: 3389-40
• Device Catalogue Number: 3389-40
• Device Lot Number: VA1XLR9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2019
• Initial Date FDA Received: 07/22/2019
• Supplement Dates Manufacturer Received: 08/08/2019; 11/04/2019; 01/09/2020
• Supplement Dates FDA Received: 08/30/2019; 11/05/2019; 01/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1